Senior Support Specialist- Lab Operations

Posted 4 Days Ago
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North Chicago, IL, USA
Hybrid
31-55 Hourly
Senior level
Healthtech • Pharmaceutical
The Role
Plans and executes QC laboratory validation activities, audits validation documentation, leads investigations and CAPA actions, supports cGMP quality systems, reviews maintenance routines and SOPs, prepares qualification samples, and manages purchasing requisitions, purchase orders, and invoice resolution through SRM/ECC.
Summary Generated by Built In
Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:
The Senior Support Specialist plans and executes validation activities, processes shopping carts and requisitions in SRM/ECC to ensure timely delivery of the goods and services required to support the business. Under the direction of the Laboratory Operations Support Lead, this role supports implementation of the QC Laboratories’ validation program. Key responsibilities include auditing commissioning and validation documentation; leading and documenting investigations; implementing corrective and preventive actions; drafting and reviewing QC Laboratory standard operating procedures; reviewing and approving critical planned maintenance routines; preparing laboratory samples for qualification; supporting the establishment of plant quality systems; creating RCEs; and managing purchasing activities.

Responsibilities

  • Responsible for participating in implementation and maintenance of the effectiveness of the Quality System.

  • Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

  • Executes tasks as assigned to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.

  • Maintains a change control program for the validated/qualified systems to assure their capability of continuing to meet quality requirements.

  • Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.

  • Ensure completion of validation activities within the allowed time and cost.

  • Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.

  • Manage and process the SRM shopping cart / ECC requisition queue to ensure timely processing of POs.

  • Ensure shopping carts, requisitions, and POs include the required documentation, correct category code, and are compliant with purchasing policies and procedures.

  • Participate in invoice resolution regarding changing purchase orders as needed.

Qualifications

  • High School/GED is required. Technical school completion/certification preferred.
  • 6+ years of overall experience in Manufacturing, Quality or Engineering
  • Good verbal and written communication skills.
  • Good problem solving and analytical skills.
  • Good interpersonal relations / communications skills.
  • Good negotiation skills.
  • Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Skills Required

  • High School diploma or GED
  • Technical school completion or certification
  • 6+ years of overall experience in Manufacturing, Quality, or Engineering
  • Verbal and written communication skills
  • Problem-solving and analytical skills
  • Interpersonal and communication skills
  • Negotiation skills
  • Knowledge of quality and compliance management
  • Knowledge of regulations and standards affecting API, bulk drug, or finished goods manufacturing

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

AbbVie Insights

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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